Questions Ask question Search Order By: ActiveCategoryClear Filter 0 Votes 1 Ans Are there examples of audit trail review that are less cumbersome than what Agilent is building into its software? 1.34K viewsDrugsPharmaceutical 0 Votes 1 Ans Can you talk about addressing the challenges of peak integrations in auto mode instead of manual? 1.22K viewsDrugsPharmaceutical 0 Votes 1 Ans Is it ever acceptable to delete data in the eyes of the FDA? 1.43K viewsDrugsPharmaceutical 0 Votes 1 Ans At some point, there must be an administrator for every system who will have access to modify or delete records, how do you recommend dealing with this potential data integrity problem? 1.27K viewsDrugsPharmaceutical 0 Votes 1 Ans Is a vendor postal audit enough to satisfy GMP requirements? 1.38K viewsDrugsPharmaceutical 0 Votes 1 Ans When samples are processed, is an audit trail comment enough or is an approval process also necessary? 1.29K viewsDrugsPharmaceutical 0 Votes 1 Ans Is x-ray inspection harmful to food or pharmaceutical products? 1.45K viewsDrugsPharmaceutical 0 Votes 1 Ans Is x-ray inspection harmful for those who operate the equipment? 1.17K viewsDrugsPharmaceutical 0 Votes 1 Ans Who regulates and monitors the use of x-ray systems within facilities that use the technology to inspect food and other consumables? 1.68K viewsDrugsPharmaceutical 0 Votes 1 Ans What are some built-in safeguards in today’s x-ray systems used for the inspection of consumable products, including foods? 1.04K viewsDrugsPharmaceutical 0 Votes 1 Ans What is the “Pharmaceutical Current Good Manufacturing Practices (CGMPs) for the 21st Century: A Risk-Based Approach”? 1.31K viewsDrugsPharmaceutical 0 Votes 1 Ans How are companies using innovation and technology to connect with consumers? 1.27K viewsDrugsPharmaceutical 0 Votes 1 Ans Will new data systems eliminate all need for procedural controls? 1.64K viewsDrugsPharmaceutical 0 Votes 1 Ans When software is updated my, how much revalidation is required? 1.30K viewsDrugsPharmaceutical 0 Votes 1 Ans How do you deal with automatic updates of Windows or antivirus programs? 1.23K viewsDrugsPharmaceutical 0 Votes 1 Ans When a new PC is implemented, is it necessary to revalidate the software? 1.27K viewsDrugsPharmaceutical 0 Votes 1 Ans Once a vendor is audited, is there a recommended time within which that vendor should be re-audited? 1.10K viewsDrugsPharmaceutical 0 Votes 1 Ans Regarding GMP lab data integrity: once data are required, can they be modified under any circumstances? 1.14K viewsDrugsPharmaceutical 0 Votes 1 Ans What should the auditing approach be for software such as the CDS that is no longer supported by the vendor but is still being used within the validated state? 1.24K viewsDrugsPharmaceutical 0 Votes 1 Ans Software sometimes has complicated calculations or algorithms in it, for example, for the integration of chromatograph, is it necessary for the software user to validate the results? 1.18K viewsDrugsPharmaceutical « Previous 1 2 … 127 128 129 130 131 … 283 284 Next » Question and answer is powered by anspress.net
